Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023790
Status:
TERMINATED
Last Update Posted:
2011-08-24
First Post:
2001-09-13
Brief Title:
Photodynamic Therapy in Treating Patients With Skin Cancer or Solid Tumors Metastatic to the Skin
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase I Trial of PC 4-PDT NSC 676418 for Cutaneous Malignancies
Status:
TERMINATED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells This may be effective treatment for skin cancer and cancer that is metastatic to the skin
PURPOSE Phase I trial to study the effectiveness of photodynamic therapy in treating patients who have either squamous cell or basal cell carcinoma of the skin or solid tumors metastatic to the skin
PURPOSE Phase I trial to study the effectiveness of photodynamic therapy in treating patients who have either squamous cell or basal cell carcinoma of the skin or solid tumors metastatic to the skin
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose MTD of silicon phthalocyanine 4 Pc 4 when administered with a fixed dose of light in patients with advanced cutaneous malignancies
Determine the MTD of the light when administered with a fixed dose of study drug in these patients
Determine the pharmacokinetics of Pc 4 in these patients
Determine the clinical antitumor response in patients treated with this regimen
OUTLINE This is a dose-escalation study
Patients receive silicon phthalocyanine 4 Pc 4 IV over 2 hours on day 1 followed by light therapy over 30-60 minutes on day 2 Treatment repeats in 6 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of Pc 4 and a fixed dose of light until the maximum tolerated dose MTD of Pc 4 is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD for Pc 4 is determined additional patients are treated with a fixed dose of Pc 4 2 dose levels below the MTD and escalating doses of light until the MTD is determined The MTD of light is defined as above
Patients are followed at 6 weeks or 8 weeks if treated lesion on lower extremity has not healed and then every 3 months thereafter
PROJECTED ACCRUAL A total of 25-30 patients will be accrued for this study annually
Determine the maximum tolerated dose MTD of silicon phthalocyanine 4 Pc 4 when administered with a fixed dose of light in patients with advanced cutaneous malignancies
Determine the MTD of the light when administered with a fixed dose of study drug in these patients
Determine the pharmacokinetics of Pc 4 in these patients
Determine the clinical antitumor response in patients treated with this regimen
OUTLINE This is a dose-escalation study
Patients receive silicon phthalocyanine 4 Pc 4 IV over 2 hours on day 1 followed by light therapy over 30-60 minutes on day 2 Treatment repeats in 6 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of Pc 4 and a fixed dose of light until the maximum tolerated dose MTD of Pc 4 is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD for Pc 4 is determined additional patients are treated with a fixed dose of Pc 4 2 dose levels below the MTD and escalating doses of light until the MTD is determined The MTD of light is defined as above
Patients are followed at 6 weeks or 8 weeks if treated lesion on lower extremity has not healed and then every 3 months thereafter
PROJECTED ACCRUAL A total of 25-30 patients will be accrued for this study annually
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CASE-1Y97 | OTHER | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |
| U01CA062502 | NIH | None | None |
| P30CA043703 | NIH | None | None |
| CWRU-1Y97 | OTHER | None | None |
| NCI-T99-0007 | None | None | None |